Methods for making precision applicators

ABSTRACT

A method for forming an applicator comprises steps of: creating a digital geometric representation of the structure, the target structure having a flatness ratio; forming the applicator using the digital geometric representation of the target structure, the applicator having a target structure contacting surface; and disposing an active agent upon the target structure contacting surface of the applicator.

FIELD OF THE INVENTION

The invention relates to methods for making implements for applyingactive agents to a target structure. The invention relates particularlyto methods for making implements custom fitted to precisely apply activeagents to a target structure.

BACKGROUND OF THE INVENTION

Agents for affecting target structures are well known. Temperatureaffects may be induced by the application of hot or cold agents to thetarget. The appearance of a target may be affected by cosmetic anddecorative agents. Electric current, voltages, and electric and magneticfields may be applied to a target using local applicators. Forbiological targets, surface properties may be impacted by the use oftopical application of moisturizers, medicaments and other treatmentactives.

The effectiveness of the active agent may be impacted by the nature ofthe applicator available to facilitate the interaction of the activeagent with the target structure. Typical applicators are less thanprecise with respect to their conformance to the target structure andthe use of one-size, or a few sizes, fits all tends to compromise theactual performance of the active agent.

What is needed is a precision application implement adapted to thegeometry of the target structure to yield an improved active agentperformance and methods for making the applicator.

SUMMARY OF THE INVENTION

In one aspect, a method for forming an applicator comprises steps of:creating a digital geometric representation of the structure, the targetstructure having a flatness ratio; forming the applicator using thedigital geometric representation of the target structure, the applicatorhaving a target structure contacting surface; and disposing an activeagent upon the target structure contacting surface of the applicator.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGURE provides a schematic perspective view of an embodiment of theinvention.

DETAILED DESCRIPTION OF THE INVENTION

In one aspect the applicator comprises a first structural element havinga shape determined according to a digital geometric representation, orotherwise created digital geometric representation of a targetstructure. The first structural element may be flexible.

As used herein the term flexible means that the three-dimensionalgeometry of the element may be altered without any permanent deformationof the element's geometry.

As used herein, the term self-supporting means that the element retainsa substantial portion of a defined three-dimensional shape without theaid of external support structures when resting on a horizontal surfacein air.

As used herein, the term single-dose means an implement comprisingsufficient active agents to afford a user only a single application ofthe active agent via the applicator.

As used herein, the term disposable refers to implements intended to bediscarded after use rather than durable, or semi-durable implementsintended for multiple uses either with or without the reapplication ofan active agent.

In one embodiment, the applicator is a durable item suitable for washingby hand or in a dishwasher or clothing washing machine.

In one embodiment, the applicator of this invention includes an outersurface that may be dry and cleaner and easier for the consumer tohandle. Due to the custom conformal fit to the target structure, forexample a part of a human body, the applicator may be configured to havea low removal force. This may be accomplished through a combination ofthe conformal nature of the applicator and/or selected application ofadhesive agents on controlled areas of the applicator, and/or otherfastening means (for example, ear hooks, an elastic band, hook and loopstraps, etc.). The three-dimensional scan of the target structure may beacquired using 3D scanners as are known in the art. An Artec Spider,available from the Artec Group, Palo Alto, Calif., is an exemplary 3Dscanner. Using a smartphone such as an iphone 6 from Apple, Cupertino,Calif., and an app such as 123D Catch from Autodesk is another exampleof a process for creating a digital geometric representation of thetarget structure. The digital geometric representation of the targetstructure may be used as a whole or may be partitioned with only aportion of the total scan being used to define the shape of thestructural element. Further, portions of the geometry derived from thescan may be removed or edited from the scan. For example, holes may becut out from the scan data to aid with vision, breathing, or other bodyfunctions.

In one embodiment, a representation of a negative of at least a portionof the target structure may be created using known methods such ascurable conforming mesh structures, heat-shapeable mesh structures,casting compounds such as plaster of Paris or clay. The completednegative of the target structure portion may then serve as the targetfor the geometric scan to provide the geometry of the target structureafter appropriate processing to yield the surface common to the negativeand the actual target structure itself. In one embodiment, the targetsurface scan may be accomplished by any known physical probe scanningmethod such as contact profiling using a stylus or an array ofmechanically movable elements such as a pin art scanner.

In one embodiment, the target structure may be replicated as a physicalrepresentation, in whole or as a set of discrete parts. The replicatedstructure, or portion thereof, may be fabricated with ancillary portions(e.g. flanges) to facilitate the use of the fabrication as a formingmold upon which an applicator which is a negative of the targetstructure or portion may be cast or otherwise formed such as bythermoforming or vacuum forming a web or film to the shape of thenegative.

The formed element is considered to have a geometry determined accordingto the digital geometric representation of the target structure. Afterthe formed element has been created, the active agents determined fromthe diagnostic analysis may be printed or otherwise disposed upon theformed element(s).

In one embodiment, the forming mold may comprise at least one channelenabling the application of an active agent to the mold contactingsurface of the applicator as or after the applicator is formed upon themold but prior to removal of the applicator from the mold. The locationof the channel(s) and the portions of the mold surface to which theyextend may be general in nature or may be specifically located accordingto common target surface features or locations determined according to adiagnostic scan of the target surface.

In one embodiment, the geometry of the scanned target structure may bemodified to add features to the formed element. As an example, theportions of a mask associated with a scanned subjects eyes, ears, mouth,or nostrils may be adapted in the geometry to facilitate the removal ofthese portions after the applicator is formed from the mold portions.Further modifications may include the addition of features for thepurpose of securing the mask in place upon the target structure, such ashooks, flaps, and slots for attaching straps to the applicator. Pressuresensitive adhesives may be disposed upon the target structure contactsurface of the applicator as a means of securing the applicator in placeupon the structure.

In one embodiment, the portions of the target structure selected tocorrespond to portions of the applicator may be selected according to afunction relationship between portions of the target structure. In suchan embodiment, a user's jaw may be selected as a portion distinct fromthe remainder of the user's face such that a complete mask consisting ofa jaw and the remainder may be fabricated and may include articulatinghinged elements allowing the jaw of the completely assembled mask toarticulate in a fashion mirroring the articulation of the user's jaw,when the mask is in use. Alternately, breaks, scores, programmedbending, hinging, or stretch elements may be added to any portion of theapplicator.

In one embodiment, the portions of the replicated target structure maybe connected by hinges or similar elements to yield a unitary mold uponwhich the applicator may be formed as described above. The formedapplicator may subsequently have active agents applied and then beassembled to a final form ready for use in applying the active agents tothe surface of the target structure.

The portions of the replicated target structure may be solid, or theymay be formed as a hollow shell or as a shell having a honey-combed orsimilar internal network of struts supporting the external surface ofthe shell. Such a supported shell may be formed to reduce the amount ofmaterial necessary for forming the portions.

The respective portions of the formed elements may comprise flanges,slots and tabs, tongues and grooves, alignment indicators, and othersuch means to facilitate the combination of the portion associatedelements into a combined whole associated with the target structure. Theportions may be formed as a clamshell like structure comprising a livinghinge over at least a portion of the overall element to enable thestructure to be folded into a usable applicator in the shape of thetarget structure. The portions may be fixedly or releasably attached toeach other suing adhesives, clips or other known means.

In one embodiment, the formed element may be inverted such that thesurface intended for contact with the target structure becomes moreeasily accessed. As an example, a formed mask of a human face may beinverted such that the portion of the mask intended to contact the tipof the nose of the wearer of the mask, is outside rather than inside themask. The now external surface may have one or more active agentsapplied using any appropriate technique such as spraying, dipping orprinting, and the formed element may subsequently be re-invertedreturning the target surface contact portion to the interior of themask.

In one embodiment, one or more active agents may be applied to a sheetstock before it is formed over the external surface. The active agentsmay be applied in a uniform fashion or different types and or amounts ofactive agents pixel by pixel. For example, ink jet printing may be usedto first print actives onto sheet stock. In addition, these printedactives may be printed in a pre-distorted pattern such that they areapplied in a first location at a first thickness in order to achieveactives in a second desired location and thickness after the distortionthat occurs in the forming process. These one or more active agents maybe applied as pre-distorted to the sheet stock before forming such thatthe active agents will achieve the intended final location at theappropriate thickness on the final custom applicator element.

In some embodiments, sheet stock consists of a forming sheet stock of amaterial such as PET, LDPE, HDPE, PS, EVA foam or laminates andcombinations and blends of these materials and other materials. In someembodiments forming operation is thermoforming, vacuum forming, orhydroforming. In some embodiments, nonwoven or woven substrate may beformed alone or in combination with another sheet stock. For example,sheet stock and nonwoven laminate with the nonwoven on the innerskin-contact side of the applicator.

Fabricating a replica of the structure may facilitate the printing orapplication of the active elements by enabling the creation of portionswhich afford the application apparatus easier access to the surfaces ofthe formed elements. Additionally, the portions when separate, may be,for example, flatter and easier to ship. As an example, a human face,fabricated as a single element, has a depth associated with the distancebetween the edge of the subjects face (i.e. at the ear) and the tip ofthe subject's nose. Alternatively, half of the same subjects face,formed upon a mold derived from a scan of the subject, has a depthassociated with an imaginary plane passing through the tip of the noseand the edge of the subjects face. As another example, the depth of ahemisphere of radius r, is r but the depth of a section of that sphere,taken between two points spaced 90 degrees upon the surface of thesphere is only approximately 0.29 r. Applying actives to portions of anoverall negative of a structure, is facilitated by effectivelyflattening the overall negative by parsing the structure and forming aset of elements which may be assembled after the appropriate applicationof active materials to the portions.

The flatness of a structure may also be considered in terms of aflatness ratio defined as the ratio of a projected area (projected froma top down normal to a horizontal supporting surface) to an actualprintable surface area. In one example, a sheet of paper has a flatnessof 1.0, whereas a full face scan of a Caucasian face has a flatness ofabout 0.6, whereas a half of the same face has a flatness of about 0.9.Flatness ratio closer to 1.0 is easier to spray uniformly and also onecan achieve higher loading with fewer number of spray coating passes.Flatness ratio closer to 1.0 are easier to spray coat from a fixed Zheight XY spray system that can be easier and less expensive to operatewhen compared to a spray system involving a multi axis arm (for thesprayer and or the surface) or any other type of conformalcoating/printing system for applying materials to a non-flat surface.

In one embodiment, forming the structural element as a set of elementswherein each member of the set is flatter than the overall targetstructure, provides the benefits of enabling easier deposition of activeagents to the structural elements as the set members are flatter, aswell as the benefit of flattening the forming mold element portionsassociated with the structural elements. Flatter mold portions mayrequire less material for their formation as well as less time tomanufacture and less build space in an additive manufacturing systemused for the fabrication. In one embodiment, the applicator may befabricated from a transparent or translucent material to reduce theconspicuousness of the applicator upon the target structure. As anexample, a transparent face mask applicator would attract significantlyless attention to the user than a white or otherwise opaque mask whenthe user sought to wear the applicator in public such as during theirdaily commute.

In any embodiment, indicia, artwork, decorations of other visibleelements may be added to the applicator using adhesives of by knownprinting techniques. The indicia etc may be added either before or afterthe structure is formed to its final useable shape.

The digital geometric representation data may be used withoutalteration, or the geometry of the representation may be altered, suchas with a digital data processing system, to yield a new geometryderived, but differing, from the target structure geometry. Thegeometric differences may be imparted to the new geometry for thepurpose of enabling the structural element to be used in the applicationof mechanical forces to the target structure. Mechanical devices may beadded (e.g. levers, ratchets, moveable sections, and other known means)to impose forces upon the underlying target structure. The geometry maybe altered to accommodate the reality that the physical applicator willhave a non-zero thickness while also matching at least a portion of thegeometry of the target surface.

In one embodiment, one or more target structure contacting portions ofthe applicator possesses conformal fit to the target structure, whilethe geometry of one or more non-contacting portions of the applicatormay be fabricated to provide additional function and/or appearance.Functional features may be incorporated to improve the ability of theapplicator by a consumer, manufacturer, distributor or retailer tohandle, place, or otherwise manipulate the applicator. Exemplaryfunctional features include one or more: grips, handles, toggles & strapreceiving elements. Additional functional features may help maintain theposition of the applicator in relation to the target structure. Suchfeatures may include elements such as an elastic band or tie receiving,attaching or anchoring element.

With respect to appearance features, a non-target-structure-contactingportion of the applicator, such an externally-facing surface, or side ofthe applicator, may be altered any of a number of ways. Rather thanincorporating the geometry of the representation, it may be shaped inthe design of a selection of available designs, or a custom designprovided by the consumer, manufacturer, distributor or retailer.Exemplary designs or likenesses of people, characters, and drawingsavailable commercially may be utilized. The likeness of Elvis Presley,Darth Vader, Christie Brinkley, Wonder Woman, Scooby-Doo or otherlikenesses, may be used. Furthermore, indicia or signal elements may bepresent, for example, a portion of the applicator may change color toindicate a suitable wearing time has been achieved. Alternately,directions such as massage points, massage directions or paths may beindicated with printed arrows or otherwise indicated. These may becoupled with structural features that assist in applying acupressure oracupuncture treatments.

In one embodiment, interface geometry may be added to the geometryderived from the representation for the purpose of enabling therepresentation-derived geometry to be merged with the externally facingelement.

In one embodiment, the target structure may be a body portion of amammal such as a human face, or other portion such as a limb, joint, orportion thereof of a mammal.

In one embodiment, the target structure may be associated with anapplicator selected from a limited array of applicators as analternative to a precise custom applicator. As an example, a scan, setof images, or other analysis of the target structure may be used toidentify which element of a provided array of structures would be mostsuited to use for the application of an active to the target structure.The analysis could indicate that a particular applicator selected fromthe provided array of structures would provide sufficient precision inthe application of the active to remove the need for a completely customapplicator.

In one embodiment, the representation, images, or other analysis may beused to determine a metric including facial size, surface area,perimeter, ear to ear distance, flatness of the face as determined usingthe normal distance between a vertical plane bisecting both subject earsand the tip of the subject's nose, or other target surface dimensionalmetrics. The range of the metric, or combination of metrics, may be usedto define a limited set of applicators intended to be applicable to theentire range of metric values—e.g. small medium, large, x-large,covering the range. In embodiments where combinations of metrics areutilized, a multi-dimensional array of applicators may be configured forselecting an appropriate applicator according to the metrics of theparticular user of subject.

The representation, images, or analysis may be used to determinedimensions associated with the location of features of the targetsurface. Using a face as an example, the location, size and shape ofelements including the eyes, nostrils, or mouth may be determinedaccording to their respective distances from a center line of the face.These locations, sizes and shapes may then be used to project thosefeatures upon an applicator selected from the array or set of potentialapplicators and openings for the selected features may then by cutthrough the applicator to provide eye holes, nostril or mouth openings.

In one embodiment, the use of the locations, sizes, and shapes of targetsurface elements may be used to provide a custom fit to applicatorswithout providing applicators conformed to the three-dimensionalgeometry of the target surface. As an example, a flat facial mask may becustomized by projecting the location of eyes, nostrils and mouth onto aflat facila mask substrate and creating openings associated with thosefeatures according to a scan or analysis of the target user's face inorder to provide a low cost option with a relatively high degree ofcustom conformal fit to the user. By controlling for the differencebetween the 3-D scan data and the projection of that data onto the flatmask substrate, such that the created openings are disposed at theappropriate locations. Openings may be created using laser cutters orother means appropriate to cutting the applicator substrate. Additionalscores or cuts may be added to the flat substrate to enhance the abilityof the applicator to conform to the target surface. The outer perimeterof the applicator may be sized and cut according to the size and shapeof the target surface intended for coverage.

The digital geometric representation, or image data may be furtherutilized as a diagnostic scanning tool by evaluating the data of therepresentation for geometric signatures identified as therapeuticindicators or triggers. The representation data may include visiblelight, variously polarized light, a particular narrow wavelength oflight, ultra-violet, infrared, and/or ultra-sonic data associated withthe representation of the target surface. The various data sets of therepresentation may be used as inputs to various diagnostic assessmentsfor the purpose of identifying areas of opportunity for therapeutictreatment of the target structure.

As an example, a scan of a face may be analyzed to identify wrinkledskin, or the precursor geometric signatures known to indicate skinregions susceptible to or progressing toward a wrinkled condition.

The results of the diagnostic scan may be incorporated into the firststructural element by way of indicia configured in the structure. Theindicia may take the form of relative changes in the structure such asthe texture, opacity, and/or color of the structural element atlocations of opportunity identified from analysis of the diagnostic scandata.

The indicia may be used to indicate those portions of the surface of thestructural element where a beneficial active material may be disposedsuch that placement of the structural element adjacent to the targetstructure may result in contact between the active material and thetarget structure.

In one embodiment, the location of the indicia may serve as depositionsites for active agents including therapeutic or cosmetic elements forthe purpose of imparting therapeutic or cosmetic effects to thecorresponding portions of the target surface. Such elements may beapplied to the first structural element by hand, using a computercontrolled robotic pick-and-place system, or by way of athree-dimensional printer. A 3Dn series, or tabletop series conformaldispensing system, available from nScrypt, Inc. of Orlando, Fla., is anexemplary printer for the deposition of the elements. For digitallyinstructed deposition systems of active agents to the first structuralelement, e.g. a three-dimensional printer, the actual indicia need notbe printed or otherwise incorporated into the manufacture of the firststructural element.

In one embodiment, the applicator and active agents are printed in thesame process using a multiple extrusion head system, such as a HyrelSystem 30 printer available from Hyrel LLC, of Norcross, Ga.

In one embodiment, active agent may be uniformly sprayed onto theapplicator using any type of spray heads, such as from NordsonCorporation. These spray heads may be mounted onto XY scanning tables ormulti-axis robotic arms to facilitate coating or operated in a hand heldfashion. Electrospray, dip coating, electroplating, powder coating,anodizing, or other methods may be used as well to apply active agentsor other materials to the structural element surface. Alternately,discrete zones, lines, or dots of active agent could be applied to theapplicator surface using a material jetting approach, such as theNordson Pico Jet valve.

In one embodiment, the active agents may be embedded or infused withinthe applicator material itself, such as Cupron Enhanced materialsavailable from Cupron of Richmond, Va.

In one embodiment, the applicator may be fabricated as a system ofmultiple layers. In this embodiment, an inner, surface contact layer maybe comprised of a first polymeric or thermoplastic or thermoset materialselected for the purpose of holding and subsequently transferring anactive agent to the surface. The inner layer's first material may lenditself to be more conformable to the target structure's response topressure and/or surface topography displacement. For the applicator ofmultiple layers, a second polymeric or thermoplastic or thermosetmaterial may be used to fabricate an outer layer intended to providesupport for the inner layer including the option to provide much or allthe flexible structure for the multiple layer applicator. The outerlayer may also hold various therapeutic implements such as electricalelements, active agents which react exothermically to the addition ofwater, or thermal agents.

For the applicator of multiple layers, the first material and the secondmaterial may be the same material composition or may differ. For examplethe modulus, compressibility, and/or tackiness properties may singly bedifferent or differ in any combination. Where the two materials differ:the outer material may be stiffer and/or possess a higher shore hardnessvalue and/or a different color and/or a higher bending modulus than thefirst material of the inner layer. As another example the inner materialmay be softer and/or be more compressible and/or be tackier and/or be adifferent color and/or have a different Modulus of elasticity than thematerial of the outer layer.

The multiple layers may be fabricated concurrently or in a sequentialfashion with one of the layers being fabricated prior to the otherlayer(s). Interactive sequential fabrication is contemplated whereinafter a portion of one layer is fabricated, and then a portion ofanother layer is fabricated followed by a return to fabricate adifferent portion of the original one layer. The active agents may bedeposited upon any layer at any time after the appropriate portion ofthe target layer is fabricated.

In one embodiment, the outer layers may include one or more functionalor appearance features. In one example, the inner layer may be onlypartially, or not at all self-supporting, while the outer layer may besubstantially or completely flexible.

In one embodiment of the applicator of multiple layers, the outer layerof the applicator may be selected from a limited array of outer layersinto which a custom fit inner layer is fabricated. In one embodiment,the inner layer may be fabricated with an external surface shaped orcontaining features to permit it to attach or adhere to an outer layerof the applicator. In this embodiment, the outer layer may be selectedfrom a limited array of pre-determined outer layers. As an example, atleast a portion of the external surface shape of the inner layerconforms to at least one or more corresponding portions of the innersurface of the outer layer such that the two layers adhere to oneanother as is, or with the assistance of an adhesive, tacky resin,mechanical fastening, thermal lamination, or other means for at leastreleasably fastening the two layers together. As another example,mechanical fasteners or interlocks may be included with one attachmentelement affixed to, or comprising a portion of the external surface ofthe inner layer, and a corresponding mating attachment element affixedto, or comprising one or more corresponding portions of the innersurface of the outer layer. One example, of many known examples, is asnap fastener (also called press stud, popper, snap or tich) whichcomprises a pair of interlocking discs, made out of a metal or plastic,commonly used in place of buttons to fasten clothing and for similarpurposes. The two interlocking (interference fit) discs make up a usefulattachment system wherein the first disc is the one attachment elementand the second disc is the mating attachment element.

The outer layer selected from the limited array of pre-determined outerlayers may be reusable. A portion or the entirety of an inner layer maybe removed or separated from the outer layer and discarded after use.Subsequently, at least a portion or a complete new inner layer may beaffixed to the reusable outer layer. The new portion or complete innerlayer may be derived from the original scan(s) or may be from adifferent scan.

Active agents may comprise active ingredients, carriers, chassis,emulsions, hydrogels, adhesives, process aides (such as thickeners,rheology modifiers, etc.). Active agents may further comprise a releaselayer to help active agents transfer from the applicator to the targetsurface. Active agents may include adhesive materials, active chemicalagents, absorbent materials such as absorbent gel materials or absorbentfoam materials placed according to either the diagnostic scan orrelative to identifiable features. As an example, it may be desirable todispose an absorbent foam material along cheekbones, brow or nose of ascanned user's facial mask, the disposition sites may be determinedaccording to the geometry of the representation rather than according tothe diagnostic scan of the user. Active agents may be in one or morephysical forms, including but not limited to: foams, liquids, powders,films, fibers, creams, gels, hydrogels, encapsulated active agents,solids, combinations of these forms and other forms. Some examples ofactive agents include but are not limited to: moisturizer, anti-aging,anti-wrinkle, skin tone control, anti-irritation, sensates (e.g.menthol), heating or cooling chemistries, skin tightening, hair removal,hair regrowth, fungicide, antibacterial, antiviral, surfactants,cleaning agents, copper ion eluting (such as from Cupron of Richmond,Va.), antioxidants, vitamins, sunscreen, rejuvenation agents, woundhealing agents, sebum management agents, astringents, exfoliates,anti-inflammatory, leave on, overnight, dry skin, itchy skin, crackedskin, peptides, acne, scar treatments, sore muscles, medicamentsincluding pharmacological actives to treat disease states or other acuteor chronic issues such as eczema, rashes, acne, cancer, cold sore,Psoriasis, Rosacea, Vitiligo, warts, diaper rash, Herpes, fungal nailinfection, Actinic Keratosis, ulcers, corns, calluses, shingles, poisonivy, and insect bites. Further, the medicaments, includingpharmacological actives, can go beyond topical effect and be designedfor transdermal delivery of an active into the bloodstream or otherinternal tissue—such as in many therapies. Examples of therapies, bothprescribed and un-prescribed include: nicotine and hormone supplements.

Exemplary active agents for cosmetic changes to the target structureinclude: fingernail polish, toenail polish, deodorant, primer, lipstick,lip gloss, lip liner, lip plumper, lip balm, lip conditioner, lipprimer, lip boosters, concealer, foundation, powder, rouge, blush,blusher, contour powder/creams, highlight, bronzer, mascara, eyeliner,and setting materials, scents, perfume or fragrance compositions (e.g.essential oils).

In one embodiment, the inclusion of one or more scents, perfume orfragrance compositions may be applied to the applicator for subsequentdeposition to the target structure. However, a portion, or all, of theincluded one or more scents, perfume or fragrance compositions may actas experience agents. The experience agent provides a smell in theenvirons of the applicator when in use. For example, the smell providedbye a fragrance to suggest outdoor flower garden aroma may be desirablewhen applying cosmetic agents to the face of a consumer/wearer.Experiential agents need not necessarily be located on the targetstructure contact surface of the applicator. The agents may be locatedin a region not in contact with the target structure, such as on anon-contacting portion of the application side of the applicator oranywhere on any applicator side that is non-contacting to the targetstructure. The experience agent may be selected to accompany a selectedappearance feature. In one embodiment, the indicia may comprise theactive agent deposited upon the first structural element withoutalterations to the relative color or texture of the application site.

The active agents may be releasably deposited upon the first structuralelement such that the active agents will be substantially transferredfrom the first structural element to the corresponding locations of thetarget surface as or after the first structural element is brought intothe proximity of, or actual contact with, the target structure.

In another example, a baseline scan may be made of a knee joint whenthere are no issues with the joint. Subsequent to the baseline scan, ata time when there is an issue with the joint, a subsequent scan may bemade to identify changes in the geometry and surface temperature of therespective portions of the joint due to inflammation, or other causes.The representations may then be used for the purpose of generating ageometry associated with the joint and taking into consideration thebaseline and current state of the joint. The geometry may be used tocreate a first structural element precisely matching the current stateor modified from the current state using data from the baseline scan tocreate a modified geometry with the intention of selectively applyingcompression to the inflamed joint upon application.

The structural element may then serve as a target structure contactsurface and may be combined with an outer shell element, or secondstructural element, having a geometry wherein there is an interfaceportion matched to a portion of the first structural element such thatthe outer shell and first structural element may be combined to form ahollow shell having an inner surface associated with the target surfaceand an interior volume derived from a therapeutic intent associated withthe representation data for the joint. The combination may define acavity between the elements. The location and volume of the cavity maybe defined using data from the diagnostic scan.

In this example, the cavity of the combination shell may then be atleast partially filled with a heating or cooling agent for the purposeof the precise application of relative heating or cooling of portions ofthe affected joint determined according to the representation data. Thefirst structural and/or outer shell elements may be fabricated toinclude insulating portions, or to have structural features adapted forthe subsequent installation of insulating elements to control thoseportions of the target structure and/or external environment subjectedto the effects of the heating or cooling agents. In this manner, theexposure to the therapeutic temperature active agent may be preciselylimited to only the portions of the target structure where such exposureis desired.

In one embodiment, the face may be scanned for geometry and also scannedfor type, location, and amount of active elements. Then, a selfsupporting 3D mask may be printed with active elements on the innersurface for delivery to a consumer's face.

In another example, the face may be scanned for geometry and then thegeometry processed to create a mechanical treatment plan for the face.The applicator, or series of applicators, can then through mechanicalmeans alone and/or by using active elements apply forces to the face tohold the face into a new geometry, thus providing a face lift mask.

The first structural element and outer shell elements may be fabricatedusing either traditional machining methods, or the elements may befabricated using additive manufacturing methods such asstereo-lithography or selective powder sintering techniques.

The elements or target surface mold or forming surface may be createdusing any polymer, thermoplastic or thermoset material. Examples includeABS, Nylon, polyolefin, polyester (e.g. PET, PLA), thermoplastics orelastomeric materials to impart an elastomeric nature to the elements.Photopolymer (SLA or continuous liquid interface printing, i.e. CLIP),sintered particles (e.g. SLS), binderjet particles, or any other methodsof additive manufacturing may also be used. Metal, wood, ceramics, sand,wax, and other cast able, machine able or formable materials may also beused. The flexibility of the elements may also be altered by theinclusion of physical hinge elements in the design geometry of theelements. Hinges or other breaks in the applicator may be used tofacilitate how the applicator is placed around a body part, such asaround the elbow.

The target structure may be evaluated to define a level of flexibilitydesired in the first structural element and/or the combination of thefirst structural element and the outer shell element. The definedflexibility may subsequently be utilized to inform the element design inaddition to the materials and fabrication technique selection for theelements in order to provide elements created with consideration for theflexibility or range of motion etc. of the underlying target structure.

The first structural element may comprise component elements enablingthe application of electric current, voltage and/or electrical ormagnetic fields to portions of the target structure. Electrodes,electrical coils and other necessary components may be disposed upon thesurface of the element or embedded or printed within the element suchthat, with the addition of a power sources such as a battery,photovoltaic solar cell, line voltage or other electrical power source,the desired energy may be applied to the target.

The geometry of the applicator may be varied from that of the target toprovide accu-pressure benefits via the applicator. Accu-punctureelements may be incorporated into the applicator directly or aperturesassociated with desired accu-puncture sites may be provided as part ofthe customized applicator. Indicia may be added to indicate beneficialmassage sites.

In one embodiment, the applicator could have integrated electroniccomponents to serve a variety of purposes. For example, the applicatorcould have integrated and printed electrical traces. These traces couldconnect a power source (such as a coin cell battery, printed battery,fuel cell, plug to the wall, or other power source) to actuators,sensors, or energy emitters. Example of actuators and energy emittersinclude LEDs, vibration sources, actuators to locally create adisplacement to apply pressure, massage elements, thermoelectric heatingand cooling elements, and electromagnets. The applicator may includestructures enabling the attachment of such power sources and energyemitters as well.

In one embodiment, the integrated electronic components may beintegrated into the outer layer and/or the inner layer of the applicatorof multiple layers. Further, integrated electronic components mayprovide an experience function while using the applicator. Examplesinclude connectivity to smartphone or audio devices such that music maybe played using audio speaker elements integrated into a facialapplicator mask during applicator use. As another example, they mayinclude transmission elements, connection to or parts of or a completevirtual reality system. For the example of a facial treatment applicator(e.g. a mask) the wearer can enjoy virtual reality content during theuse of the applicator.

In one embodiment, the applicator may be provided as part of a consumerproduct kit. The kit may comprise the applicator element, or elements,and one or more active agents. The active agents may be predisposed uponthe first structural element, or may be provided in a form suitable forapplication to the structural element by the consumer/user of the kitelements. The kit may further include a key (map) indicating the pointsof deposition for the active agent upon the surface of the structuralelement according to indicia, or as an alternative to the indicia.

The elements of the kit may be provided in a plurality of ways. In oneembodiment, the structural element and active agent may be prepared,frozen, and provided in combination as a frozen article to be appliedfrozen, or to be thawed and used. In one embodiment, the structuralelement and active agent may be combined and sealed to shield the activeagent from environmental effects. The structural element and active maybe provided enclosed in a sealed pouch, or the perimeter of thestructural element may be adhered to a film element to enclose theactive agent within a chamber shielded from the external environment.

As shown in the FIGURE: a kit 1000 comprises a first structural element100. The first structural element 100, comprises indicia, 120, an activeagent 130, an insulating element 140 and an electrical element 160. Thekit 1000 further comprises a second structural element 200 configured toreceive the first structural element resulting in the creation of acavity (not shown) between the first and second structural elements.

For both the structural elements which are 3D printed, and the flexibleelements which are formed upon molds which were 3D printed, theproduct/applicator may include various indicia formed as part of themanufacturing of the product. Such indicia may include brand logos ornames, as well as the date of the representation, the time and date ofmanufacture, a serialized ID number, the active agents applied to themask, a product expiration, useful life indicator or best if used bydate derived according to the date of manufacture and the appliedchemical agents.

In one embodiment, the created elements may be provided in packagingcustomized to better preserve the integrity of the product offering. Inone embodiment, the package may comprise a polymeric film which in turnhas been ring-rolled, gusseted, or otherwise geometrically altered suchas is described in U.S. Pat. No. 5,366,782. Such geometric alterationimpart elasticity to the film enabling the package to achieve a highdegree of conformity to enclosed products across a wide range of actualproduct sizes, thereby minimizing the enclosed volume and any quantityof controlled atmosphere which may be used to further stabilize andprotect the product. In some embodiments, the package may include a filmor barrier film and or a carton or rigid sleeve and one or more elementsto affix or align the applicator to a rigid element inside the flexiblefilm.

The volume of the package may be pressurized and may comprise air or aspecifically selected gas (e.g. argon, nitrogen) to preserve the productand protect the product by providing a degree of structural integrity bythe pressurization of the package.

In one embodiment, the package comprises a custom shaped tray orsupport. In one embodiment, the package comprises release liner eitherin flat sheet, cut and or folded sheet, or partially or entirely formedinto a custom shape.

A range of packages may be provided such that a higher degree oftailoring of the package to the product may be achieved. A range such assmall, medium, and large may be provided separate from or in conjunctionwith the custom sizing features described above.

The package may comprise any known packaging materials such as wood,glass, polymer materials, foils, laminates, paper materials and othermaterials as are known in the art. In one embodiment, the package maycomprise traditional boxes, films, sachets, bags, cans, and other knowpackage forms. The package exterior may include indicia associated withbrands, materials and other information associated with the product aswell as network locations where more information associated with theproduct may be found. The packaging material may be a flexible pouchwhere a mask or mask portion is contained within. The pouch would havethe necessary barrier properties to maintain the target shelf life,moisture levels, and integrity of the active agents and the applicator.The pouch may or may not be gusseted with one or more gussets. The pouchmay further have an insert. The insert may be a single stiff sheet. Theinsert may be custom fit to the applicator according to the digitalgeometric representation. The insert may be a U shaped insert to createa fixed volume within the flexible pouch. The pouch may be inflated orheld at a fixed volume through air trapping to maintain a fixed volume.The insert may be box with 6 faces, 5 faces, 4 faces, 3 faces, or 2faces. The insert may have attachment points for the applicator to alignand hold the applicator in place during shipment. The attachment pointsmay be posts, fasteners, removable adhesive, or any other suchattachments. The pouch may have transparent regions or any type ofprint, reverse print, metallization, or other coatings and decorationtechnologies.

The product may comprise stand-offs attached to, or separate from, theproduct itself to facilitate maintaining space between the package wallsand the product, as well as to facilitate the stacking of a plurality ofpackaged products.

The packaged product may include space filling materials disposedbetween the surfaces of the product and the interior surfaces of thepackage to provide space and protection for the product as it isenclosed in the package.

The products may include extraneous flanges or other structures for thepurpose of enabling the nesting or stacking of a multitude of productswithin a single package while maintaining the integrity of appliedactive materials. Release liners of silicone or wax coated sheets may bedisposed between stacked products to facilitate separation of theproducts.

The data from scanning the target structure used previously increasingthe product/formed element(s), may be further used as an input tocreating a custom package for the product wherein the shape of thepackage is also associated with the shape of the target surface and theproduct. Such a custom package could be manufactured using a mold andknown vacuum and thermo forming processes. In one embodiment, bar codesmay be used to associate and enable the tracking and coordinatedfabrication of products and packages

The package may be hermetically sealed and may also comprise atransparent or translucent portion to enable viewing of the productenclosed within the sealed package. The sealed package may comprise apre-determined atmosphere as described above. The sealed package mayinclude indicia providing information related to the recipient, the dateof manufacture, the shipping destination and other relevant information.

The applicator may be acquired by the user via a retail shoppingexperience. That experience may include steps of: scanning the subjecttarget structure, or providing a scan of the structure, such as a scanusing a Microsoft Kinect®, or providing data from a software scancreated from multiple subject photographs, or providing data from a CTor MRI scan of the subject target, the representation data may includeinformation for the purpose of completing a diagnostic evaluation of thetarget surface in terms of the absorption or reflectance of particularelectromagnetic radiation frequencies, or the local appearance ofdiscrete regions of the surface, or a evaluation of the DNA of thetarget user. The diagnostic scan may be used as the basis fordetermining specific locations upon the intended applicator for thedisposition of active agents for the purpose of addressing needsidentified in the diagnostic evaluation. A consultation with the usermay be undertaken to discuss and explain the active agent optionsavailable and the relationship between those options and theopportunities indicated by the diagnostic evaluation. The user may makeselections based upon the evaluation and or the consultation. The user'sselections may be provided to the fabrication location such that theactive agents associated with the user's selections may be incorporatedinto the applicators fabricated as a result of the representation andsubsequent selections. A test applicator may be fabricated as a part ofthe retail experience to enable the user to experience the fit of theproposed applicator as part of assisting the user in understanding thefit related benefits of the custom created applicator as opposed to aone size fits all applicator of a flat web applicator when applied to atypically non-flat target surface. Subsequent to the acquisition of scandata and user inputs, the applicators may be fabricated as describedabove, either at the retail location or remotely, and then provided tothe user. The user may receive the applicators either by returning tothe retail location or via a mail delivery service. The retailexperience may include subsequent scans of the user to determine anddemonstrate alterations in the target surface due to the use of theapplicators and associated active agents. Additional applicators may befabricated in association with the subsequent scans. The additionalapplicators may include revised applicator geometries as well as revisedactive agents and active agent deposition targeting due to changes inthe target.

A. A method for forming an applicator, the method comprising steps of:

-   -   a. creating a digital geometric representation of the structure,        the target structure having a flatness ratio;    -   b. forming the applicator using the digital geometric        representation of the target structure, the applicator having a        target structure contacting surface; and    -   c. disposing an active agent upon the target structure        contacting surface of the applicator.

B. The method according to paragraph A, wherein the step of: forming theapplicator using the digital geometric representation of the targetstructure, the applicator having a target structure contacting surfacecomprises: creating a physical representation of at least a portion ofthe target structure according to the digital geometric representation;forming the applicator using the physical representation of the targetstructure, the applicator having a target structure contacting surface.

C. The method according to paragraph B, wherein the step of: creating aphysical representation of at least a portion of the target structureaccording to the digital geometric representation, further comprisescreating a set of physical representations corresponding to a set ofportions of the digital geometric representation of the targetstructure.

D. The method according to any of paragraphs: B, or C, wherein the stepof: creating a physical representation of at least a portion of thetarget structure according to the digital geometric representation,further comprises creating active agent deposition channels as part ofthe physical representation.

E. The method according to any of paragraphs: B, C, or D, wherein thestep of forming the applicator comprises thermoforming at least aportion of the applicator using the physical representation of thetarget structure.

F. The method according to any of paragraphs: B, C, D, or E, wherein thestep of: creating a physical representation of at least a portion of thetarget structure according to the digital geometric representation,further comprises creating a physical representations corresponding toan altered digital geometric representation of the target structure.

G. The method according to any of paragraphs: B, C, D, E, or F, whereinthe step of: creating a physical representation of at least a portion ofthe target structure according to the digital geometric representation,further comprises creating a physical representation of at a portion ofthe target structure having a flatness ratio which is higher than theflatness ration of the target structure.

H. The method according to any of paragraphs: B, C, D, E, F, or G,further comprising the step of removing a portion of the formedapplicator.

I. The method according to any of paragraphs: B, C, D, E, F, G, or H,further comprising the step of scanning the target structure to create adigital diagnostic scan of the target surface.

J. The method according to paragraph I, further comprising the step ofdisposing the active agent upon the applicator according to the digitaldiagnostic scan.

K. The method according to paragraph A, wherein the step of: forming theapplicator using the digital geometric representation of the targetstructure, the applicator having a target structure contacting surfacecomprises: creating a physical representation of at least a portion ofthe negative of the target structure according to the digital geometricrepresentation; the physical representation having a target structurecontacting surface.

L. The method according to paragraph K, wherein the step of: creating aphysical representation of at least a portion of the negative of thetarget structure according to the digital geometric representation,further comprises creating a set of physical representationscorresponding to a set of portions of the negative of the targetstructure according to the digital geometric representation.

M. The method according to any of paragraphs: K, or L, wherein the stepof: creating a physical representation of at least a portion of thenegative of the target structure according to the digital geometricrepresentation, further comprises creating active agent depositionindicia as part of the physical representation.

N. The method according to any of paragraphs: K, L, or M, wherein thestep of: creating a physical representation of at least a portion of thenegative of the target structure according to the digital geometricrepresentation, further comprises creating a physical representationscorresponding to an altered digital geometric representation of thetarget structure.

O. The method according to any of paragraphs: K, L, M, or N, wherein thestep of: creating a physical representation of at least a portion of thenegative of the target structure according to the digital geometricrepresentation, further comprises creating a physical representation ofat a portion of the negative of the target structure having a flatnessratio which is higher than the flatness ratio of the target structure.

P. The method according to any of paragraphs: K, L, M, N, or O, furthercomprising the step of removing a portion of the created applicator.

Q. The method according to any of paragraphs: K, L, M, N, O, or P,further comprising the step of scanning the target structure to create adigital diagnostic scan of the target surface.

R. The method according to any of paragraphs: K, L, M, N, O, P, or Q,further comprising the step of disposing the active agent upon theapplicator according to the digital diagnostic scan.

The dimensions and values disclosed herein are not to be understood asbeing strictly limited to the exact numerical values recited. Instead,unless otherwise specified, each such dimension is intended to mean boththe recited value and a functionally equivalent range surrounding thatvalue. For example, a dimension disclosed as “40 mm” is intended to mean“about 40 mm.”

Every document cited herein, including any cross referenced or relatedpatent or application and any patent application or patent to which thisapplication claims priority or benefit thereof, is hereby incorporatedherein by reference in its entirety unless expressly excluded orotherwise limited. The citation of any document is not an admission thatit is prior art with respect to any invention disclosed or claimedherein or that it alone, or in any combination with any other referenceor references, teaches, suggests or discloses any such invention.Further, to the extent that any meaning or definition of a term in thisdocument conflicts with any meaning or definition of the same term in adocument incorporated by reference, the meaning or definition assignedto that term in this document shall govern.

While particular embodiments of the present invention have beenillustrated and described, it would be obvious to those skilled in theart that various other changes and modifications can be made withoutdeparting from the spirit and scope of the invention. It is thereforeintended to cover in the appended claims all such changes andmodifications that are within the scope of this invention.

What is claimed is:
 1. A method for forming an applicator, the methodcomprising steps of: creating a digital geometric representation of atarget structure, the target structure having a flatness ratio; formingthe applicator using the digital geometric representation of the targetstructure, the applicator having a target structure contacting surface;and disposing an active agent upon the target structure contactingsurface of the applicator; and sizing the outer perimeter of theapplicator to the target structure contacting surface.
 2. The methodaccording to claim 1, wherein the step of: forming the applicator usingthe digital geometric representation of the target structure, theapplicator having a target structure contacting surface comprises:creating a physical representation of at least a portion of the targetstructure according to the digital geometric representation; forming theapplicator using the physical representation of the target structure,the applicator having a target structure contacting surface.
 3. Themethod according to claim 2, wherein the step of: creating a physicalrepresentation of at least a portion of the target structure accordingto the digital geometric representation, further comprises creating aset of physical representations corresponding to a set of portions ofthe digital geometric representation of the target structure.
 4. Themethod according to claim 2, wherein the step of: creating a physicalrepresentation of at least a portion of the target structure accordingto the digital geometric representation, further comprises creatingactive agent deposition channels as part of the physical representation.5. The method according to claim 2, wherein the step of forming theapplicator comprises thermoforming at least a portion of the applicatorusing the physical representation of the target structure.
 6. The methodaccording to claim 2, wherein the step of: creating a physicalrepresentation of at least a portion of the target structure accordingto the digital geometric representation, further comprises creating aphysical representations corresponding to an altered digital geometricrepresentation of the target structure.
 7. The method according to claim2, wherein the step of: creating a physical representation of at least aportion of the target structure according to the digital geometricrepresentation, further comprises creating a physical representation ofat a portion of the target structure having a flatness ratio which ishigher than the flatness ration of the target structure.
 8. The methodaccording to claim 2, further comprising the step of removing a portionof the formed applicator.
 9. The method according to claim 2 furthercomprising the step of creating a digital diagnostic scan of the targetstructure.
 10. The method according to claim 9, further comprising thestep of disposing the active agent upon the applicator according to thedigital diagnostic scan.
 11. The method according to claim 1, whereinthe step of: forming the applicator using the digital geometricrepresentation of the target structure, the applicator having a targetstructure contacting surface comprises: creating a physicalrepresentation of at least a portion of the negative of the targetstructure according to the digital geometric representation; thephysical representation having a target structure contacting surface.12. The method according to claim 11, wherein the step of: creating aphysical representation of at least a portion of the negative of thetarget structure according to the digital geometric representation,further comprises creating a set of physical representationscorresponding to a set of portions of the negative of the targetstructure according to the digital geometric representation.
 13. Themethod according to claim 11, wherein the step of: creating a physicalrepresentation of at least a portion of the negative of the targetstructure according to the digital geometric representation, furthercomprises creating active agent deposition indicia as part of thephysical representation.
 14. The method according to claim 11, whereinthe step of: creating a physical representation of at least a portion ofthe negative of the target structure according to the digital geometricrepresentation, further comprises creating a physical representationscorresponding to an altered digital geometric representation of thetarget structure.
 15. The method according to claim 11, wherein the stepof: creating a physical representation of at least a portion of thenegative of the target structure according to the digital geometricrepresentation, further comprises creating a physical representation ofat a portion of the negative of the target structure having a flatnessratio which is higher than the flatness ratio of the target structure.16. The method according to claim 11, further comprising the step ofremoving a portion of the created applicator.
 17. The method accordingto claim 11 further comprising the step of creating a digital diagnosticscan of the target structure.
 18. The method according to claim 17,further comprising the step of disposing the active agent upon theapplicator according to the digital diagnostic scan.
 19. A method forforming an applicator, the method comprising steps of: creating adigital geometric representation of a target structure; forming theapplicator using the digital geometric representation of the targetstructure, the applicator having a target structure contacting surface;and disposing an active agent upon the target structure contactingsurface of the applicator; and sizing the outer perimeter of theapplicator to the target structure contacting surface.